Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients

Covid19 Clinical Trial

Official title:

Clinical Outcomes of High Dose Vitamin D Versus Standard Dose in COVID-19 Egyptian Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04738760
• Other study ID #: COVID-VIT-D
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vitamin D is a secosteroid hormone which may have beneficial role in reducing COVID-19 adverse outcomes by first regulating the renin angiotensin system (RAS). Recent studies on animal in which acute respiratory distress syndrome (ARDS) was induced, showed that vitamin D lead to pulmonary permeability reduction by modulating RAS activity as well as the expression of the angiotensin-2 converting enzyme (ACE2). During COVID-19, downregulation of ACE2 leads to cytokine storm in the host, causing ARDS. In contrast, an experimental study conducted on mice in which ARDS was induced chemically, revealed that vitamin D admiration contributed to mRNA and ACE2 proteins levels improvement, ADRS milder symptoms as well as less lung damage.

Additionally, vitamin D had shown antiviral effects on several previous studies, that though to be exerted either by antimicrobial peptides induction which subsequently had direct antiviral action or through immunomodulatory and anti-inflammatory effects.

In addition, vitamin D stabilizes physical barriers which prevent viruses from reaching tissues susceptible to infection. Finally, previous studies demonstrated that hypovitaminosis D is accompanied by various comorbidities including diabetes mellitus, hypertension, chronic cardiovascular and respiratory diseases, and cancers, all medical conditions that are considered risk factors of COVID-19 infection deterioration and even high mortality rate.

The objective of this study is to evaluate whether supplementation with high-dose vitamin D improves the prognosis of patients diagnosed with COVID-19 compared to a standard dose of vitamin D.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 65 years.

2. COVID-19 hospitalized patients with pneumonia confirmed by chest X-ray or CT scan.

3. RT-PCR Confirmed infection with COVID-19 or strongly suspected infection with pending confirmation studies.

4. Presence of acute respiratory distress syndrome (ARDS).

5. Having either peripheral capillary oxygen saturation (SpO2) = 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio = 300 mmHg.

Exclusion Criteria:

1. Vitamin D supplementation in the previous month.

2. Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D.

3. Organ failure requiring admission to a resuscitation or high dependency unit.

4. Pregnant women.

5. Participation in another simultaneous clinical trial.

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Covid19
• Cytokine Release Syndrome
• Cytokine Storm
• Vitamin D Deficiency

Locations

Country	Name	City	State
Egypt	Teachers Hospital	Cairo	Please Select

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	Misr International University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospitalization	Length of hospital stay	Two weeks
Primary	In-hospital mortality	Death during hospitalization	Two weeks
Primary	Clinical status improvement using six category ordinal scale	Change in six category ordinal scale. The categories were defined as follows: 1) patient discharged, 2) hospitalization not requiring supplemental oxygen, 3) hospitalization requiring supplemental low-flow oxygen, 4) hospitalization requiring high-flow supplemental oxygen, 5) hospitalization requiring invasive mechanical ventilation, 6) death.	Two weeks
Primary	Change in gas exchange	Difference between ratio of partial pressure of arterial oxygen (PaO2) to the fraction of inspired oxygen (FiO2) at baseline, and before discharge	Two weeks
Primary	Time to increase in oxygenation	Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2)	48 hours
Secondary	Change in Lactate dehydrogenase (LDH) levels	Change in levels of Lactate dehydrogenase (LDH) between baseline and before discharge	Two weeks
Secondary	Change in C-reactive protein (CRP) levels	Change in levels of C-reactive protein (CRP) between baseline and before discharge	Two weeks
Secondary	Change in serum ferritin levels	Change in levels of serum ferritin between baseline and before discharge	Two weeks
Secondary	Occurrence of secondary infection	Occurrence of sepsis	Two weeks
Secondary	Occurrence of at least one severe adverse event	Any serious or severe adverse event that might happens during hospital stay	Two weeks
Secondary	Need for mechanical ventilator or intensive care unit (ICU) support	Admission to ICU or usage of mechanical ventilator	Two weeks